This is a Phase I clinical trial evaluating the combination of vandetanib and dasatinib during and after radiation therapy (RT) in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG).
This trial will estimate the maximum safe dose of vandetanib and dasatinib which can be administered during the 6 weeks of local RT in children with newly diagnosed DIPG.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Two oral investigational agents (vandetanib \[VEGFR2, RET, and EGFR inhibitor\] and dasatinib \[bcr-abl, PDGFRA and B, src, lck, yes, and c-kit inhibitor\] will be administered during and after local RT, which is the only standard therapy for children with DIPG.
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
To estimate the maximum tolerated dose (MTD) of the combination of vandetanib and dasatinib administered concurrently with RT in pediatric research participants with newly diagnosed DIPG
Time frame: April 2012
To determine the toxicities associated with the chronic use of vandetanib and dasatinib
Time frame: July 2012
To characterize the pharmacokinetics of vandetanib and dasatinib in pediatric research participants
Time frame: July 2012
To evaluate the influence of specific polymorphisms (e.g., CYP3A4/5) on the pharmacokinetics of vandetanib and dasatinib administered in combination
Time frame: July 2012
To explore the association between plasma angiogenic factors and response to current therapy
Time frame: July 2012
To evaluate the pharmacodynamics of dasatinib in target receptors and pathways in peripheral mononuclear cells
Time frame: July 2012
To describe the research participants' and parents' perspective of the quality of life of children with newly diagnosed DIPG enrolled on this phase I trial
Time frame: July 2012
To describe the quality of life of parents of pediatric research participants with newly diagnosed DIPG enrolled on this phase I trial
Time frame: July 2012
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